Monitoring Subjects With Fluid-Management Issues In the Home Environment
A Study for Monitoring Subjects With Fluid-Management Issues Using Repeated Measurements In the Home Environment
1 other identifier
observational
23
1 country
1
Brief Summary
This study is designed to validate ease-of-use for the CoVa Monitoring System, along with simple statistical parameters such as reproducibility and inter-subject agreement between test and reference devices.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2014
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 10, 2014
CompletedFirst Posted
Study publicly available on registry
July 15, 2014
CompletedJuly 23, 2014
July 1, 2014
1 month
July 10, 2014
July 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ease of Use
Investigate ease of use associated with the CoVa Monitoring System: determine if subjects could use the test device on a daily basis, and if the components of this system (Sensor, Gateway, Web-based System) were indeed operational
Each subject will be measured once per weekday over a 6 week period
Secondary Outcomes (1)
SKin irritation and reproducibility
Each subject will be measured once per weekday over a 6 week period
Study Arms (1)
Cohort 1: Subjects taking diuretic medication
All subjects will be in the same group, Cohort 1
Eligibility Criteria
Subjects will be volunteers from Riverside Meadows Estates. Subjects will be taking one or more diuretic medication(s) prescribed by a physician
You may qualify if:
- Subject is between 21 (twenty-one) and 90 (ninety) years of age at screening.
- Subject will have a current prescription for a diuretic medication.
- Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study.
- Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition.
You may not qualify if:
- Subject is participating in another clinical study that may affect the results of either study.
- Subject is unable or not willing to wear electrode patches as required.
- Subject has skin sensitivity to adhesive or hydrogel materials used in electrode patches.
- Subject has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device.
- Subject is considered by the PI to be medically unsuitable for study participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Riverside Meadows
Riverside, California, 92505, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Banet, PhD
Baxter Healthcare Corporation
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2014
First Posted
July 15, 2014
Study Start
April 1, 2014
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
July 23, 2014
Record last verified: 2014-07